OneSource Specialty Pharma’s Bangalore facility maintains US FDA compliance with VAI classification
US FDA concludes inspection of OneSource’s flagship site with Voluntary Action Indicated status, confirming regulatory adherence
OneSource Specialty Pharma, a contract development and manufacturing organisation (CDMO) focused on multi-modality drug products, announced that its flagship facility in Bangalore, India, has maintained compliance with United States Food and Drug Administration (USFDA) regulations following a recent inspection.
The inspection, conducted from 20 March to 28 March 2025, concluded with the issuance of a Form 483 that included four observations. Based on the company’s submitted response and commitments, the USFDA has classified the outcome as “Voluntary Action Indicated” (VAI). This officially brings the inspection process to a close and confirms the continued compliance status of the site.
Neeraj Sharma, Managing Director & CEO of OneSource Specialty Pharma, commented, “The successful closure of our latest USFDA inspection is a pivotal moment in our journey, and we are very pleased with this outcome demonstrating our exemplary compliance status. Our flagship facility, Unit 2, is the cornerstone of our manufacturing capabilities in Drug Device Combinations (DDC), biologics drug substances, and complex injectables. This milestone validates our deep-rooted commitment to quality and is crucial as our partners prepare to launch key GLP-1 products in late FY26. We are excited to advance into our next significant commercial phase.”
The Unit 2 facility serves as a key site for the company’s drug-device combination programmes, biologics, and complex injectable platforms. The VAI classification enables OneSource to continue supporting global pharmaceutical partners, particularly in preparation for upcoming commercial product launches.